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N Engl J Med. 2019 Jun 27;380(26):2541-2550. doi: 10.1056/NEJMsa1901109. Epub 2019 Apr 3.

Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement.

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From the Division of Cardiology, Duke University Medical Center (S.V.), the Duke Clinical Research Institute (S.V., Z.L., D.D., A.S.K.), and the Department of Biostatistics and Bioinformatics, Duke University (A.S.K.) - all in Durham, NC; the Division of Cardiology, Department of Medicine, University of Colorado, Aurora (J.D.C.); Baylor Scott and White Heart Hospital, Plano (M.J.M.), and the Division of Cardiology, Department of Medicine, University of Texas Southwestern Medical Center, Dallas (D.J.K.) - both in Texas; the Division of Cardiology, Hackensack Meridian School of Medicine at Seton Hall University, Hackensack, NJ (C.E.R.); the Division of Cardiothoracic Surgery, Medstar Heart and Vascular Institute and Georgetown University, Washington, DC (V.H.T.); the Division of Cardiology, William Beaumont Hospital, Royal Oak, MI (G.H.); the University of Pittsburgh School of Medicine, Pittsburgh (T.G.G.); the Divisions of Cardiology (H.C.H.) and Cardiothoracic Surgery (J.E.B.), University of Pennsylvania, Philadelphia; and the Philip R. Lee Institute of Health Policy Studies, University of California, San Francisco, San Francisco (R.G.B.).



During the introduction of transcatheter aortic-valve replacement (TAVR) in the United States, requirements regarding procedural volume were mandated by the Centers for Medicare and Medicaid Services as a condition of reimbursement. A better understanding of the relationship between hospital volume of TAVR procedures and patient outcomes could inform policy decisions.


We analyzed data from the Transcatheter Valve Therapy Registry regarding procedural volumes and outcomes from 2015 through 2017. The primary analyses examined the association between hospital procedural volume as a continuous variable and risk-adjusted mortality at 30 days after transfemoral TAVR. Secondary analysis included risk-adjusted mortality according to quartile of hospital procedural volume. A sensitivity analysis was performed after exclusion of the first 12 months of transfemoral TAVR procedures at each hospital.


Of 113,662 TAVR procedures performed at 555 hospitals by 2960 operators, 96,256 (84.7%) involved a transfemoral approach. There was a significant inverse association between annualized volume of transfemoral TAVR procedures and mortality. Adjusted 30-day mortality was higher and more variable at hospitals in the lowest-volume quartile (3.19%; 95% confidence interval [CI], 2.78 to 3.67) than at hospitals in the highest-volume quartile (2.66%; 95% CI, 2.48 to 2.85) (odds ratio, 1.21; P = 0.02). The difference in adjusted mortality between a mean annualized volume of 27 procedures in the lowest-volume quartile and 143 procedures in the highest-volume quartile was a relative reduction of 19.45% (95% CI, 8.63 to 30.26). After the exclusion of the first 12 months of TAVR procedures at each hospital, 30-day mortality remained higher in the lowest-volume quartile than in the highest-volume quartile (3.10% vs. 2.61%; odds ratio, 1.19; 95% CI, 1.01 to 1.40).


An inverse volume-mortality association was observed for transfemoral TAVR procedures from 2015 through 2017. Mortality at 30 days was higher and more variable at hospitals with a low procedural volume than at hospitals with a high procedural volume. (Funded by the American College of Cardiology Foundation National Cardiovascular Data Registry and the Society of Thoracic Surgeons.).

[Indexed for MEDLINE]

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